In general, vaccines can be harvested, then, after suitable treatment, can be lyophilized and kept at low temperatures, typically around 0 degrees Celsius (° C.), for extended periods of time prior to use. While lyophilization may be a suitable approach to preservation of some substances, some vaccines and other medicaments do not readily lyophilize and, in addition, dilution of a lyophilized product can be difficult to accomplish, especially in a sterile environment, by the end user.
Some vaccines and other liquid medicaments may need to be kept at even colder temperatures in order to give the vaccine a commercially reasonable shelf life and/or to promote viability or efficacy of the medicament.
For example, during clinical trials by Argos Therapeutics, Inc., plastic tubes with removable lids have been used to cryogenically store custom-prepared liquid vaccines derived from a patient's own cells, in a frozen state, at less than about −40° C. Prior to administration, the medicament was thawed to liquid in the tube and the lid removed. Three syringes were used to extract the liquid medicament from the opened tube while the lid remained off the tube, then each syringe of liquid medicament was injected into the patient within a relatively short period of time after thaw to deliver the desired bolus dose.
Despite the above, there is a need to provide containers and/or cooperating delivery systems that are economic, reliable in dispensing volume, relatively easy to manufacture and able to withstand ultra-low and/or cryogenic temperatures, such as about or below −40° C., about or below −70° C., or even about or below −80° C., such as between about −120° C. to about −196° C. There is also a need for such devices to meet cleanliness and/or sterility standards in commercial production systems while protecting the medicaments from environmental exposure prior to and/or during administration.